Scientists Advancing Affordable Medicines, Inc. is a nonprofit 501(c)(6) organization that seeks to provide a dedicated platform for scientists to share cutting-edge research that facilitates the development of high-quality, affordable medicines, thereby improving their accessibility to patients. Because we are sharing approaches now for the affordable medicines of tomorrow, we have adopted the tradename SAAMnow.
WEBINAR: Secrets to Successful Pre-IND Meetings for 505(b)(2) NDA Drug Development
SAAMnow is continuing its series of webinars on 505(b)(2) NDAs and will present the fourth session (fifth overall) on March 26, 2021. The session will be up to 2 hours duration with two speakers and two presentations of 30-40 minutes followed by chat questions and answers.
Why Should You Attend:
This session will focus on the preparation of a pre-IND Meeting Package for 505(b)(2) product development, and will feature one speaker (Aloka Srinivasan) that participated in SAAMnow’s successful workshop on Demystifying 505(b)(2) Development: Navigating the Scientific, Regulatory, Legal, and Business Complexities (October 16-18, 2019, Philadelphia, PA) and one speaker (Candis Edwards) from the pharmaceutical industry. The workshop highlighted the diversity, simplicity and complexity of the 505(b)(2) application process, and via these webinars we want to continue to fill the basic educational gap in understanding and characterizing the 505(b)(2) pathway by giving participants an opportunity to learn from experts in this field.
SAAMnow offers individuals the opportunity to potentially impact the availability of affordable medicines through cutting-edge research. SAAMnow is looking for individuals involved/interested in research & development, formulation/manufacturing science, analytical chemistry, clinical science, statistics, quality systems, regulatory science, marketing, and allied disciplines associated with the development, manufacturing, testing, and commercialization of high quality affordable medicines. Affordable medicines are broadly defined as those that take advantage of abbreviated regulatory filing pathways, resulting in development cost savings that can then be passed on to patients. Examples include conventional generic pharmaceuticals, biosimilars, and products filed via hybrid regulatory pathways, such as the 505(b)(2) route.
Our annual membership dues: $100.